ES2979139T3 - Radiofrequency ablation catheter with spiral structure and device thereof - Google Patents

Abstract

A radiofrequency ablation catheter having a spiral structure and its equipment are described. The radiofrequency ablation catheter has a long strip-shaped catheter body. A spiral electrode holder is arranged at the front end of the catheter body. Multiple electrodes (2) are arranged on the electrode holder. A control handle (8, 20) is arranged at the rear end of the catheter body. Wall fixing adjustment wires (6) having various structures can be arranged on the radiofrequency ablation catheter, so that the radiofrequency ablation catheter having a spiral structure can be adapted to target lumens of different diameters, and so that the electrodes (2) on the electrode holder have a good wall fixing state. (Automatic translation with Google Translate, without legal value)

Description

DESCRIPTION

Radiofrequency ablation catheter with spiral structure and device thereof

Background

Technical field

The present invention relates to the technical field of interventional medical devices and relates to a radiofrequency ablation catheter having a spiral structure, and to a radiofrequency ablation device including the radiofrequency ablation catheter.

Related technique

In a radiofrequency ablation system, a radiofrequency ablation catheter is a key component to be introduced into a human vessel and deliver radiofrequency energy. A radiofrequency electrode is installed in a holder at a front end of the radiofrequency ablation catheter, and the holder is used to carry the radiofrequency electrode, and it is expanded to perform fixation to the wall before the radiofrequency ablation starts and retracted and removed after the radiofrequency ablation ends. Because a radiofrequency surgery is performed by directly introducing into a human vessel, the telescopic size of the holder must be adapted to the diameter of a human vessel.

Human vessel diameters vary depending on different ablation parts. In addition, human vessel diameters also vary from person to person. For example, the diameter of a renal artery is roughly in the range of 2 mm to 12 mm and has a large difference. In the prior art, generally, the telescopic size of one electrode end of a radiofrequency ablation catheter is fixed and cannot adapt to the diameter requirements of different human vessels, and the coverage of human vessels of different diameters is relatively small. Therefore, when performing radiofrequency surgeries on different patients, it is generally necessary to change radiofrequency ablation catheters of different specifications and models. Even so, in some cases, the problem may arise that radiofrequency electrodes cannot be fixed to the wall at the same time during one surgery, which affects the effect of surgery.

A radiofrequency ablation catheter structure is classified into multiple types according to the shapes of an electrode and an electrode holder, such as a saccule-type structure, a puncture needle-type structure, a spiral structure or a flap-type structure. A radiofrequency ablation catheter for which an electrode holder is designed with a spiral shape is widely used.

For an existing coiled RF ablation catheter, an electrode holder is mainly formed in advance and then the RF ablation catheter is entered into a vessel with the help of a guiding catheter/sheath. The RF ablation catheter is moved forward or the guiding catheter/sheath is moved backward, to remove the RF ablation catheter from the guiding catheter/sheath, so that the electrode holder resumes its shape after entering a target location.

For example, an ablation catheter adapted for use with a guide wire and having a three-dimensional shaped portion carrying ring electrodes is provided in CN 104042333A (Chinese counterpart of EP 2,777,746), expansion and contraction of the three-dimensional shaped portion by pushing forward and pulling back the guide wire. For a single radiofrequency ablation catheter, a size is set in advance to shape an electrode holder. Therefore, the adaptability of the existing coiled radiofrequency ablation catheter to vessels of different diameters is limited. Therefore, in CN 102488552 A an electrophysiology (EP) catheter is provided comprising a catheter body provided with electrodes; at least a portion of the catheter body provided with electrodes is a coiled catheter; and a pull wire is fixed at the tail end of the spiral catheter and penetrates into the catheter body from the front end of the spiral catheter and can rotate and slide within the catheter body.

Compendium

The invention is defined in the attached independent claim 1. Additional embodiments of the invention are defined in the attached dependent claims.

The first technical problem to be solved by the present invention is to provide an improved radiofrequency ablation catheter having a spiral structure.

Another technical problem to be solved by the present invention is to provide a radiofrequency ablation device including the above radiofrequency ablation catheter.

To achieve the above objectives, the following technical solutions are used in this description:

A radiofrequency ablation catheter having a coiled structure includes an elongated catheter body, where a coil-shaped electrode holder is arranged at a forward end of the catheter body, multiple electrodes are arranged on the electrode holder and a control handle is arranged at a rear end of the catheter body, where

A slidable support wall fixation adjustment cable is disposed in a lumen in the electrode holder and the catheter body, and the support wall fixation adjustment cable consists of a flexible section that is remote from the control handle and a rigid section that is close to the control handle.

Preferably, a head end of the support wall fixing adjustment wire penetrates through the electrode holder, then is limited on the outside of the electrode holder and can be moved toward a direction that is away from the catheter and the electrode holder, toward a direction that is away from the catheter; a tail end of the support wall fixing adjustment wire penetrates through the catheter body and is fixed on the control handle; and the control handle is used to control the support wall fixing adjustment wire to move back and forth.

Preferably, when the supporting wall fixing adjustment wire moves forward to make the rigid section on the electrode holder and the flexible section on the outside of the electrode holder, under the effect of the rigid section of the supporting wall fixing adjustment wire, a diameter of the spiral shape of the electrode holder is reduced, the length is increased, and the spiral shape tends to be a straight line shape; and

When the wall-mounted fixing adjustment wire is removed to make the flexible section fit into the electrode holder, the electrode holder returns to its spiral shape.

Preferably, a button control component that is fixed with the rear end of the support wall fixing adjustment cable is arranged on the control handle, and the support wall fixing adjustment cable is controlled to move by changing a location of the button control component on the control handle.

Preferably, a developing head is arranged at the head end of the supporting wall fixing adjustment cable.

Preferably, the support wall fixing adjustment wire has a rearwardly extending forked adjustment wire; a head end of the forked adjustment wire is fixed at the head end of the support wall fixing adjustment wire, or a head end of the forked adjustment wire is fixed at a particular part of the flexible section, or the forked adjustment wire is a thin filament that branches from the flexible section to the outside; and a rear end of the forked adjustment wire penetrates out of a hole provided in an outer tube in the electrode holder, penetrates a hole provided in the electrode holder or the catheter body, then extends out of the catheter with the rigid section of the support wall fixing adjustment wire side by side along a lumen in the catheter body, enters the interior of the control handle and is fixed in a second control component.

Preferably, the electrode holder includes an outer tube, multiple electrodes are embedded in an outer circumference of the outer tube, multiple lumens are arranged in the outer tube, a group of thermocouple wires and radio frequency lines are arranged in each of several lumens, a group of radio frequency lines and thermocouple wires are arranged in each electrode, the radio frequency line is connected to the electrode, and the thermocouple wire and the electrode are arranged insulatingly.

Preferably, a spiral-shaped cable is arranged in the electrode holder.

A radiofrequency ablation catheter having a coiled structure includes an elongated catheter body, where a coil-shaped electrode holder is arranged at a front end of the catheter body, one or more electrodes are arranged on the electrode holder, and a control handle is arranged at a rear end of the catheter body, where

a rear section of the wall attachment adjustment cable is slidably disposed in a lumen in the catheter body; a rear end of the wall attachment adjustment cable is connected to a control component disposed in the control handle, or a rear end of the wall attachment adjustment cable penetrates through the control handle and is then connected to a control component in a peripheral device; and a front section of the wall attachment adjustment cable penetrates outside the electrode holder and is then exposed outside the electrode holder, and a front end of the wall attachment adjustment cable returns into the electrode holder and is fixed.

Preferably, the front end of the wall-fixing adjustment cable returns into the electrode holder, then returns to the rear end of the catheter body through a lumen in the electrode holder and the catheter body, and is secured to the control handle or is secured to the control component.

Alternatively, preferably, the front end of the wall fixing adjustment cable returns into the electrode holder, and is then fixed at a front end of the electrode holder.

Alternatively, preferably, the front end of the wall fixing adjustment cable returns to the inside of the electrode holder, and then penetrates outside the front end of the electrode holder and is fixed or limited on the outside; and the wall fixing adjustment cable is also a support cable.

Alternatively, preferably, the radiofrequency ablation catheter having a coiled structure further includes: a support wire disposed in a particular lumen in a connecting passage and the electrode holder, where the front end of the wall-fixing adjustment wire is fixed on the support wire; or the wall-fixing adjustment wire is a thin filament which is of the support wire and which branches outward.

Preferably, a portion of the support wire in the electrode holder is spiral-shaped, to form a spiral-shaped section.

Alternatively, preferably, there is a fixing point between a part of the wall fixing adjustment wire that is exposed outside the electrode holder and the electrode holder; and the front end and the rear end of the wall fixing adjustment wire respectively penetrate outside the rear end of the catheter body and are fixed in corresponding control components arranged in the control handle, or the front end and the rear end of the wall fixing adjustment wire respectively penetrate outside the rear end of the catheter body and penetrate through the control handle and then are connected to corresponding control components in the peripheral device.

Preferably, a particular point of the wall fixing adjustment wire that is exposed outside the electrode holder is fixed in a hole in a particular spiral section of the electrode holder.

Alternatively, preferably, the wall fixing adjustment cable is formed by multiple cable strands; a front end of each cable strand is fixed on the electrode holder; a rear end is wound around a spiral section of the electrode holder from the outside and then enters the inside of the electrode holder or the catheter body, and then penetrates out of the end of the catheter body through a lumen in the catheter body, and is fixed on a corresponding control component provided on the control handle or passes through the control handle and then is connected to a corresponding control component on the peripheral device; and the multiple cable strands are respectively used to independently control diameters of different spiral sections of the electrode holder.

Preferably, the fixing points of the multiple cable strands on the electrode holder are different from each other.

Preferably, in multiple cable strands, every two cable strands have a common fixing point on the electrode holder.

Preferably, each cable strand enters the interior of the electrode holder from a different location on the electrode holder.

Alternatively, preferably, the fixing points of the multiple cable strands on the electrode holder are the same.

A radiofrequency ablation device includes the anterior radiofrequency ablation catheter and a radiofrequency ablation host connected to the radiofrequency ablation catheter.

According to the radiofrequency ablation catheter provided in the present disclosure, supporting wall fixing adjustment wires having different structures or wall fixing adjustment wires having different structures are arranged, so that the radiofrequency ablation catheter having a spiral structure can be adapted to target lumens of different diameters, and the wall fixing states of the electrodes on an electrode holder are good. In target lumens of different diameters, the wall fixing adjustment wires are pulled, so that the wall fixing states of the electrodes arranged on the electrode holder are good. In addition, the wall fixing adjustment wire may also use a multi-wire structure, and a single wire is independently controlled, so that different spiral sections of the radiofrequency ablation catheter can be respectively controlled, thereby reducing the difficulty of adjusting a diameter of the electrode holder.

Brief description of the drawings

FIG. 1a is a schematic structural diagram of a radiofrequency ablation catheter having a coil structure according to a first embodiment;

FIG. 1b is a schematic side view of the radiofrequency ablation catheter shown in FIG. 1a; FIG. 1c is a schematic structural diagram of a control handle on the radiofrequency ablation catheter shown in FIG. 1a;

FIG. 2 is a schematic cross-sectional view of an electrode holder in the radiofrequency ablation catheter having a spiral structure according to the first embodiment;

FIG. 3 is a schematic structural diagram of a first type of support wall fixing adjustment wire in the radiofrequency ablation catheter having a spiral structure according to the first embodiment; FIG. 4 is a schematic diagram of a D-D section of the radiofrequency ablation catheter having a spiral structure when a rigid section of the support wall fixing adjustment wire is matched with the electrode holder;

FIG. 5 is an enlarged schematic local view of a part I of the radiofrequency ablation catheter having a spiral structure shown in FIG. 4;

FIG. 6a is a schematic structural diagram of the radiofrequency ablation catheter having a spiral structure when a flexible section of the support wall fixation adjustment wire mates with the electrode holder;

FIG. 6b is a schematic side view of the radiofrequency ablation catheter shown in FIG. 6a; FIG. 7a is a schematic state diagram of a control handle when a push-button control component is moved forward to feed a lead, and a rigid section of a control line mates with the electrode holder;

FIG. 7b is a schematic state diagram of the control lever when the button control component is moved rearward to pull a wire, and a flexible section of the control line mates with the electrode holder;

FIG. 8 is a schematic structural diagram of a second type of support wall fixing adjustment wire in the radiofrequency ablation catheter having a spiral structure according to the first embodiment; FIG. 9 is a schematic structural diagram of a third type of support wall fixing adjustment wire in the radiofrequency ablation catheter having a spiral structure according to the first embodiment; FIG. 10 is a schematic sectional view of the radiofrequency ablation catheter using a fourth type of support wall fixing adjustment wire according to the first embodiment;

FIG. 11 is a schematic structural diagram of a fifth type of support wall fixing adjustment wire in the radiofrequency ablation catheter having a spiral structure according to the first embodiment; FIG. 12 is a schematic structural diagram of a sixth type of support wall fixing adjustment wire in the radiofrequency ablation catheter having a spiral structure according to the first embodiment; FIG. 13 is another schematic structural diagram of the control handle in the radiofrequency ablation catheter having a spiral structure according to the first embodiment;

FIG. 14 is a schematic structural diagram of an electrode holder and a catheter body in a radiofrequency ablation catheter having a coil structure according to the invention;

FIG. 15 is a schematic cross-sectional view of the electrode holder in the radiofrequency ablation catheter having a spiral structure shown in FIG. 14;

FIG. 16 is a schematic diagram of a cross section A-A of the radiofrequency ablation catheter having a coil structure shown in FIG. 14;

FIG. 17 is an enlarged schematic view of a part II of the radiofrequency ablation catheter having a coil structure shown in FIG. 16;

FIG. 18 is a schematic diagram of another manner in which a wall fixing adjustment wire is arranged in the radiofrequency ablation catheter having a spiral structure according to the second embodiment; FIG. 19 is a schematic structural diagram of a control handle in the radiofrequency ablation catheter having a spiral structure according to the second embodiment;

FIG. 20A is a schematic diagram of an initial state of the radiofrequency ablation catheter having a spiral structure shown in FIG. 14;

FIG. 20B is a schematic side view of the radiofrequency ablation catheter having a coil structure shown in FIG. 20A;

FIG. 21 is a schematic state diagram of the radiofrequency ablation catheter having a coil structure shown in FIG. 14 in a sheath;

FIG. 22 is a schematic diagram of a state of use of the radiofrequency ablation catheter having a spiral structure shown in FIG. 14 in a relatively small vessel;

FIG. 23A is a schematic diagram of a state of use of the radiofrequency ablation catheter having a spiral structure shown in FIG. 14 in a relatively large vessel;

FIG. 23B is a schematic side view of the radiofrequency ablation catheter having a coil structure shown in FIG. 23A;

FIG. 24 is a schematic structural diagram of an electrode holder and a catheter body in a radiofrequency ablation catheter having a spiral structure according to a third embodiment;

FIG. 25 is a schematic diagram of a state of use of the radiofrequency ablation catheter having a spiral structure shown in FIG. 24;

FIG. 26A is a schematic diagram of a state of use of a control handle in the radiofrequency ablation catheter having a spiral structure according to the third embodiment;

FIG. 26B is a schematic diagram of another state of use of the control handle in the radiofrequency ablation catheter having a spiral structure according to the third embodiment;

FIG. 27 is a schematic structural diagram of an electrode holder and a catheter body in a radiofrequency ablation catheter having a spiral structure according to a fourth embodiment;

FIG. 28 is a schematic structural diagram of a support wire in the radiofrequency ablation catheter having a spiral structure according to the fourth embodiment;

FIG. 29 is a schematic structural diagram of an electrode holder and a catheter body in a radiofrequency ablation catheter having a spiral structure according to a fifth embodiment;

FIG. 30 is a schematic structural diagram of a support wire and a wall fixation adjustment wire in the radiofrequency ablation catheter having a spiral structure according to the fifth embodiment;

FIG. 31A is a schematic structural diagram of an electrode holder and a catheter body in a radiofrequency ablation catheter having a spiral structure according to a sixth embodiment;

FIG. 31B is a schematic side view of the radiofrequency ablation catheter having a coil structure shown in FIG. 31A;

FIG. 32A is a schematic structural diagram of an electrode holder and a catheter body in a radiofrequency ablation catheter having a spiral structure according to a seventh embodiment;

FIG. 32B is a schematic side view of the radiofrequency ablation catheter having a coil structure shown in FIG. 32A;

FIG. 33 is a schematic diagram of an internal structure of the electrode holder in the radiofrequency ablation catheter having a spiral structure according to the seventh embodiment;

FIG. 34A is a schematic state diagram when a wall fixation adjustment wire is pulled back and the electrode holder performs wall fixation in the radiofrequency ablation catheter having a spiral structure according to the seventh embodiment;

FIG. 34B is a schematic side view of the radiofrequency ablation catheter having a coil structure shown in FIG. 34A;

FIG. 35 is a schematic structural diagram of a wall fixation adjustment wire in a radiofrequency ablation catheter having a spiral structure according to an eighth embodiment;

FIG. 36A is another schematic structural diagram of the wall fixation adjustment wire in the radiofrequency ablation catheter having a spiral structure according to the eighth embodiment; and

FIG. 36B is yet another schematic structural diagram of the wall fixation adjustment wire in the radiofrequency ablation catheter having a spiral structure according to the eighth embodiment.

Detailed description

The technical content of the present description is described in detail below with reference to the attached drawings and specific embodiments.

First realization

As can be learned by referring to FIG. 1a to FIG. 1c, a radiofrequency ablation catheter having a spiral structure provided in the present disclosure includes an elongated catheter body. A spiral-shaped electrode holder is disposed at a forward end of the catheter body. An initial diameter of the spiral shape of the electrode holder is OD, and an initial length is A-1 (referring to FIG. 1a and FIG. 1b), and preferably, OD should be larger than the diameter of a target lumen. A control handle 8 is disposed at a rear end of the catheter body (referring to FIG. 1c). During actual manufacturing, the electrode holder may be manufactured integrally with the catheter body, and the electrode holder is part of a spiral shape at the forward end of the catheter body. Alternatively, the electrode holder may be manufactured independently and then integrally connected to the catheter body. The spiral-shaped electrode holder includes an outer tube 1 and a plurality of electrodes 1 arranged in the outer tube 1. The electrode 1 may be a block electrode or an annular electrode embedded in an outer circumference of the outer tube 1, and an upper surface of the electrode 1 may be flush with an outer surface of the outer tube 1 or be slightly higher than an outer surface of the outer tube 1, or an upper surface of the electrode 1 may be lower than an outer surface of the outer tube 1.

A lumen used to receive a support wall fixation adjustment wire 6 is provided in the electrode holder and the catheter body. The support wall fixation adjustment wires 6 are provided in corresponding lumens in the electrode holder and the catheter body (referring to FIG. 2). The support wall fixation adjustment wires 6 can slide back and forth in corresponding lumens in the electrode holder and the catheter body, and the lumen used to receive the support wall fixation adjustment wire 6 may be a central hole in the electrode holder or the catheter body, or it may be one of multiple lumens distributed on the periphery of the center. As shown in FIG. 1a, a head end of the support wall fixing adjustment wire 6 penetrates through the electrode holder, then is limited on the outside of the electrode holder, and is movable, relative to a far end of the electrode holder, toward a direction away from the catheter body. A developing head 63 is provided at a head end of the support wall fixing adjustment wire 6. As shown in FIG. 1c, a tail end of the support wall fixing adjustment wire 6 penetrates through the central hole in the catheter body and is fixed on the control handle 8. The control handle 8 is used to control the support wall fixing adjustment wire 6 to move back and forth. A button control component 9 is arranged on the control handle 8. The tail end of the support wall fixing adjustment wire 6 penetrates through the central hole in the catheter body and is then fixed on the button control component 9. The support wall fixing adjustment wire 6 is controlled to move back and forth by changing a location of the button control component 9 on the control handle 8.

For the radiofrequency ablation catheter having a spiral structure, the diameter of the electrode holder is changed by improving a structure of the support wall fixing adjustment wire 6, so that the electrode holder is easy to insert into a guide catheter/sheath and a target lumen; furthermore, after the electrode holder reaches the target lumen, the electrode holder can be restored to the natural spiral shape. As shown in FIG. 3, in the radiofrequency ablation catheter, the support wall fixing adjustment wire 6 includes two parts: a flexible section 61 which is remote from the control handle 8 (near the head end) and a rigid section 62 which is near the control handle 8 (near the tail end). It is preferred that the length of the flexible section 61 is not less than the length of the outer tube 1 of the electrode holder. Certainly, in a special case, the length of the flexible section 61 may be smaller than the length of the outer tube 101 of the electrode holder. The diameter of the spiral shape of the electrode holder can be changed by changing, using the control handle 8, an area in which the support wall fixing adjustment wire 6 coincides with the electrode holder.

When the supporting wall fixing adjustment wire 6 is moved forward to cause the rigid section 62 of the supporting wall fixing adjustment wire 6 to be on the electrode holder and the flexible section 61 of the supporting wall fixing adjustment wire 6 to be on the outside of the electrode holder, under the effect of the rigid section 62 of the supporting wall fixing adjustment wire 6, the diameter of the spiral shape of the electrode holder is reduced, the length is increased, and the spiral shape tends to be a straight line shape. In an ideal case, the electrode holder may have a straight line shape as shown in FIG. 4. When the supporting wall fixing adjustment wire 6 is retracted to cause the flexible section 61 of the supporting wall fixing adjustment wire 6 to enter the electrode holder, the electrode holder gradually bends as it enters the flexible section. The electrode holder resumes its spiral shape until the rigid section 62 is no longer in the electrode holder and only the flexible section 61 is in the electrode holder (referring to FIG. 6a). Its diameter OC is equal to or approximates a diameter of a target lumen (referring to FIG.

6b). In this case, the length A-2 of the spiral shape of the electrode holder is greater than the initial length A-1. That is, in the radiofrequency ablation catheter, the supporting wall fixing adjustment wire 6 is controlled to move forward, so that the rigid section 62 of the supporting wall fixing adjustment wire 6 coincides with the outer tube 1 of the electrode holder, to reduce the diameter of the spiral shape of the electrode holder. Therefore, the electrode holder is suitable for entering a guide catheter/sheath or a target lumen. Furthermore, when the electrode holder reaches a target lumen, the supporting wall fixing adjustment wire 6 is pulled backward, so that the flexible section 62 of the supporting wall fixing adjustment wire 6 coincides with the outer tube 1 of the electrode holder to make the electrode holder recover the spiral shape, thereby implementing wall fixing. In FIG. 7a and FIG. 7b shows a location of the button control component 9 in the control wizard 8. When the button control component 9 is moved to a location on the left side, the flexible section 61 is exposed, and the rigid section 62 mates with the outer tube 1 of the electrode holder. When the button control component 9 is moved to a location on the right side, the flexible section 61 of the support wall fixing adjustment cable 6 mates with the outer tube of the electrode holder.

In addition, when the electrode holder is naturally expanded to realize wall fixation, the wall fixation state of the electrode 1 can be slightly adjusted by further pulling the holder wall fixation adjustment wire 6, so that the electrode 1 is in close contact with a vessel wall, thereby improving the wall fixation state of the electrode 1. For the above radiofrequency ablation catheter, the holder wall fixation adjustment wire 6 is arranged on the electrode holder. After the flexible section 61 of the holder wall fixation adjustment wire 6 is matched with the outer tube of the electrode holder, the holder wall fixation adjustment wire 6 is pulled again, and a movement range of the holder wall fixation adjustment wire 6 is relatively small. Therefore, the holder wall fixation adjustment wire 6 is only used to slightly adjust the shape of the electrode holder. During the selection of a radiofrequency ablation catheter, it is recommended to select a radiofrequency ablation catheter whose OD diameter of a spiral shape is larger than or close to the diameter of a target lumen. In this way, in a process where the electrode holder automatically extends into the target lumen and recovers to the spiral shape, under the effect of a vessel wall, a close fixation to the wall can be implemented. The radiofrequency ablation catheter achieves a good wall fixation effect for a target lumen whose diameter is smaller than or equal to the initial diameter of the spiral shape. Because the diameter of a vessel of human renal artery is within a range of 2 mm to 12 mm, in order to ensure that the radiofrequency ablation catheter has good adaptability to large and small vessels, it is recommended to use the selection of a radiofrequency ablation catheter whose OD is larger than 12 mm.

Furthermore, the present disclosure also provides a radiofrequency ablation catheter with a support wall fixation adjustment wire 6 having a bifurcation (referring to FIGS. 10, 11, and 12). In this case, the initial diameter OD of the spiral shape of the electrode holder may be smaller than the diameter of a target lumen. The support wall fixation adjustment wire 6 has a bifurcation extending rearwardly from the flexible section 61, i.e., a bifurcated adjustment wire 66 in FIG. 10, FIG. 11, and FIG. 12. A head end of the bifurcated adjustment wire 66 is fixed at the head end of the support wall fixing adjustment wire 6, or a head end of the bifurcated adjustment wire 66 is fixed at a particular part of the flexible section 61, or the bifurcated adjustment wire 66 is a thin filament which is bifurcated from the flexible section 61 to the outside. A rear end of the bifurcated adjustment wire 66 penetrates out of a hole 1 provided in the outer tube 1 of the electrode holder, penetrates into a hole 15 provided in the outer tube of the electrode holder or into a hole provided in the catheter body, then extends out of the catheter with the support wall fixing adjustment wire 6 side by side along a lumen in the catheter body, enters the inside of the control handle 8, and is fixed in a second control component in the control handle 8 (or an independently arranged second control component). When the above radiofrequency ablation catheter having a spiral structure is used in a relatively large vessel, wall fixation cannot be performed after the electrode holder restores its natural spiral shape. In this case, the bifurcation (i.e., the bifurcated adjustment wire 66) of the supporting wall fixation adjustment wire 6 is pulled to increase the diameter of the spiral shape of the electrode holder, so that the electrode holder fits a vessel of a relatively large diameter. The structure and contents related to this part are described in detail later.

The technical details of the radiofrequency ablation catheter having a spiral structure provided in the first embodiment are described in more detail below.

The outer tube 1 of the electrode holder may be a single-lumen tube or a multi-lumen tube, and the outer tube 1 may be made of polymeric materials or metallic materials, for example, materials such as stainless steel or memory alloy. The outer tube 1 may be processed by using straight tube materials or bar materials, or it may be made into a tube of a special shape by using an A-section. As shown in FIG. 2 and FIG. 5, when the outer tube 1 uses a multi-lumen tube, in addition to the central hole, multiple lumens are also arranged in the outer tube 1 of the electrode holder, a group of radio frequency lines 1 and thermocouple wires 1 are arranged in each of some lumens, the thermocouple wire 1 is covered by a thermocouple wire head end insulating layer 5 to be separated from the radio frequency line 1 and the electrode 1, the head ends of each group of radio frequency lines 1 and the thermocouple wires 1 are arranged in a single electrode, a head end of the radio frequency line 1 is closely welded with the electrode 1, the head end of the thermocouple wire 1 is welded, and the head end of the thermocouple wire 1 and the electrode 1 are arranged in an insulating manner. A spiral-shaped wire 7 is also arranged in a lumen in the outer tube 1. The spiral-shaped wire 7 is fixed at the A-section in a spiral deformation area, and is used to support the spiral shape of the electrode holder. Of course, the electrode holder can directly adopt the spiral shape, so that the spiral-shaped wire 7 can be omitted. For example, when the outer tube is manufactured using a memory alloy, the arrangement of the spiral-shaped wire 7 can be omitted.

The electrode 1 is fixed on the outer tube 1, and an outer surface of the electrode 1 may be lower or may not be lower than the outer surface of the outer tube 1. The plural electrodes 1 are uniformly or non-uniformly distributed in the spiral shape of the electrode holder around a circumferential direction. The plural electrodes may be distributed on the electrode holder in a circle, more than a circle, or less than a circle. An inner surface of the electrode 1 is closely welded with the radio frequency line 1. The head ends of the thermocouple wires 1 are welded together, the thermocouple wire head end insulating layer 1 is covered at a location where the head end of the thermocouple wire 1 is welded for insulation, and the thermocouple wire head end 1 is disposed on the electrode 1. The thermocouple wire head end insulating layer 1 may be a heat shrinkable tube or other shell.

The multiple-wire wall-fixing support adjustment structures applicable to the above radiofrequency ablation catheter are described in detail using examples by referring to the attached drawings.

As shown in FIG. 3, a first type of support wall fixing adjustment cable 6 provided in the present invention includes two parts: a flexible section 61 which is near a head end and a rigid section 62. A developing head 63 may be arranged at a head end of the support wall fixing adjustment cable 6, and is used to develop and image a target lumen.

Each of the two types of support wall fixing adjustment wires shown in FIG. 8 and FIG. 9 includes a flexible section 61 and a rigid section 62, and a straight head flexible guide wire 64 or a curved head flexible guide wire 65 is further disposed at a front end of the flexible section 61 of the support wall fixing adjustment wire 6, so that the support wall fixing adjustment wire 6 can directly enter a vessel by replacing a guide catheter/sheath, thereby simplifying operations in a surgery. Because a guide catheter/sheath is omitted, the diameter of the catheter entering the vessel can be greatly reduced, which is convenient for the catheter to move.

Each of the three types of supporting wall fixing adjustment cables shown in FIG. 10 to FIG. 12 includes a bifurcated adjustment cable 66, and the structures of the three types of bifurcated adjustment cables 66 are slightly different. Specifically, in a fourth type of supporting wall fixing adjustment cable 6 shown in FIG. 10, a head end of the bifurcated adjustment wire 66 is fixed at a head end of the support wall fixing adjustment wire 6, and then extends rearward with the flexible section 61. A rear end of the bifurcated adjustment wire 66 penetrates out of the hole 1 provided in the outer tube 1 of the electrode holder, penetrates into a corresponding lumen from the other hole 15 provided in the electrode holder or in the catheter body, then extends outward of the catheter with the support wall fixing adjustment wire 6 side by side along a lumen in the catheter body, and is fixed at the second control component in the control handle 8.

In a fifth type of support wall fixing adjustment wire 6 shown in FIG. 11, the head end of the bifurcated adjustment wire 66 is fixed in a particular part of the flexible section 61, or the bifurcated adjustment wire 66 is a thin filament branching from the flexible section 61. Then, the rear end of the bifurcated adjustment wire 66 penetrates out of the hole provided in the outer tube 1 of the electrode holder, penetrates the other hole provided in the electrode holder or the catheter body, then extends out of the catheter with the support wall fixing adjustment wire 6 side by side along a lumen in the catheter body, and is fixed in the second control component in the control handle.

In a sixth type of supporting wall fixing adjustment cable 6 shown in FIG. 12, the manner in which the bifurcated adjustment cable is arranged is similar to that of a structure of the fourth type of supporting wall fixing adjustment cable. One difference is that the flexible section uses a spring structure. The bifurcated adjustment cable 66 is a thin filament which is branched off from a particular part of a spring 61-1, and the head end of the bifurcated adjustment cable 66 is fixed to the spring. The rear end of the bifurcated adjustment wire 66 protrudes out of the hole provided in the outer tube 101 of the electrode holder, protrudes into the other hole provided in the electrode holder or in the catheter body, then extends to the outside of the catheter with the rigid section 62-1 of the adjustment wire fixing to the support wall 6, side by side along a lumen in the catheter body, enters the control handle 8 and is fixed in the second control component on the control handle.

By means of the above three types of supporting wall fixation adjustment wires, after the radiofrequency ablation catheter restores the natural spiral shape in a target vessel or lumen whose diameter is larger than the initial diameter OD of the spiral shape, and if wall fixation still cannot be achieved, the bifurcated adjustment wire 66 is pulled using the second control component, to increase the diameter of the electrode holder, so that the electrode can achieve wall fixation. It should be noted that the manner in which the second control component is arranged on the control handle 8 may be the same as the manner in which the button control component 9 is arranged. The second control component may also be arranged independently with respect to the control handle 8, as in the embodiment shown in FIG. 13. After the bifurcated adjustment wire 66 and the supporting wall fixing adjustment wire 6 enter the control handle 8 side by side, the end 67 of the supporting wall fixing adjustment wire 6 is fixed on the button control component 9. A location of the button control component 9 on the control handle 8 can be changed by pressing the button control component 9, to change the shape of the electrode holder. The bifurcated adjustment wire 66 extends out of an opening provided on another side surface of the control handle 8, and the second control component 10 is fixed on the end 68 of the bifurcated adjustment wire 66. The diameter of the spiral shape of the electrode holder can be further changed by pulling the second control component 10 on the outside of the control handle 8.

In the supporting wall fixing adjustment cables shown in FIG. 10 to FIG. 12, flexible sections of multiple different structures are further provided respectively. The flexible section 61 of the supporting wall fixing adjustment cable 6 in FIG. 10 has the same structure as the flexible sections in the first three types of supporting wall fixing adjustment cables shown in FIG. 3, FIG. 8, and FIG. 9, and the flexible section 61 is constructed using a thin filament or a flexible tube. The flexible section 61 may be made of a thin filament whose diameter is smaller than that of the rigid section. The flexible section 61 and the rigid section 62 may be integrally molded using a same material or may be assembled using two thin filaments of different diameters (for example, assembled using a welding process). The flexible section 61 may also be constructed using a flexible tube. In the supporting wall fixing adjustment wire shown in FIG. 12, the flexible section 61-1 uses a spring structure. When the flexible section 61-1 is placed on the electrode holder, because a spring has a good bending property, under the effect of the spiral-shaped wire 7, the electrode holder can restore the spiral shape, and consequently the flexible section 61-1 is deformed.

The radiofrequency ablation catheter having a spiral structure provided in the first embodiment has been described above. In this embodiment, the support wall fixing adjustment wire in the radiofrequency ablation catheter having a spiral structure is improved by referring to the structure of the guide wire, but the specific functions of the two are different. In the guide wire, the flexible section is used to initially adapt to the shape of a vessel. The direction of the guide wire is changed, so that the guide wire successfully reaches a target lumen. The rigid section is used to support the guide wire. In the radiofrequency ablation catheter having a spiral structure provided in the present invention, the shape of the electrode holder is changed by controlling the electrode holder to match different areas of the support wall fixing adjustment wire 6, so that the difficulty of introducing a guide catheter/sheath by the radiofrequency ablation catheter can be reduced, the structure is simple and it is easy to operate. When the supporting wall fixing adjustment wire 6 is moved forward to match the rigid section with the spiral-shaped electrode holder 1, under the effect of the rigid section of the supporting wall fixing adjustment wire 6, the diameter of the spiral shape of the electrode holder is reduced, the length is increased, and the spiral shape tends to be a straight line shape, so that it is convenient to introduce a guide catheter/sheath, and it is also convenient for the entire radiofrequency ablation catheter to move in a target lumen. When the supporting wall fixing adjustment wire 6 is pulled back to make the flexible section match the spiral-shaped electrode holder, the spiral-shaped electrode holder recovers the spiral shape, and wall fixing can be performed. In addition, the wall fixing state of the electrode can be further improved by continuously pulling back the supporting wall fixing adjustment wire. In addition, the straight head flexible guide wire or the curved head flexible guide wire is additionally arranged at the front end of the support wall fixation adjustment wire, and the support wall fixation adjustment wire can further directly enter a vessel by replacing a guide catheter/sheath, thus simplifying operations in a surgery.

In addition, by means of the anterior supporting wall fixation adjustment wire, the difficulty of entering a human vessel by the radiofrequency ablation catheter is reduced, and an increased diameter of the spiral-shaped electrode holder can be further changed by pulling the supporting wall fixation adjustment wire, so that the adaptability of the electrode holder to target lumens of different diameters is relatively good.

In the radiofrequency ablation catheter having a spiral structure provided in the first embodiment, a supporting wall fixing adjustment wire disposed in a particular lumen in the electrode holder is used to adjust the diameter of the spiral shape of the electrode holder. In other embodiments provided in the present invention, a wall fixing adjustment wire penetrating through or wrapping around the electrode holder may be disposed in the radiofrequency ablation catheter having a spiral structure, to adjust the increased diameter of the electrode holder, so that the adaptability of the electrode holder to target lumens of different diameters is relatively good. For more information, see the following descriptions.

Description of the invention

As can be learned from FIG. 14 to FIG. 19 , a radiofrequency ablation catheter having a spiral structure provided in the present invention includes an elongated catheter body. A spiral-shaped electrode holder is disposed at a forward end of the catheter body, and a control handle 120 is disposed at a rear end of the catheter body (referring to FIG. 19 ). During actual manufacturing, the electrode holder may be manufactured integrally with the catheter body, and the electrode holder is shaped to be part of a spiral shape at the forward end of the catheter body. The electrode holder may also be manufactured independently and then integrally connected to the catheter body.

As shown in FIG. 14, the spiral-shaped electrode holder includes an outer tube 101 and one or more electrodes 102 disposed in the outer tube 101. The electrode 102 may be a block electrode or an annular electrode embedded in an outer circumference of the outer tube, and an upper surface of the electrode 102 may be flush with an outer surface of the outer tube 101 or be slightly higher than an outer surface of the outer tube 101, or an upper surface of the electrode 102 may be lower than an outer surface of the outer tube 101. The plural electrodes 102 are evenly or unevenly distributed in the spiral shape of the electrode holder around a circumferential direction. The plural electrodes may be distributed on the electrode holder in a circle, more than one circle, or less than one circle.

The outer tube 101 of the electrode holder may be a single-lumen tube or a multi-lumen tube, and the outer tube 101 may be made of polymeric materials or metallic materials, for example, materials such as stainless steel or memory alloy. The outer tube 101 may be processed using straight tube materials or bar materials, or may be made into a tube of a special shape using an A-section. As shown in FIG. 15 and FIG. 17, when the outer tube 101 uses a multi-lumen tube, in addition to a central lumen, multiple lumens are arranged in the outer tube 101 of the electrode holder, a group of radio frequency lines 103 and thermocouple wires 104 are arranged in each of a few lumens, the head ends of each group of radio frequency lines 103 and thermocouple wires 104 are arranged in a single electrode 102, a head end of the radio frequency line 103 is closely fixed with the electrode 102, for example, connected by using a welding process, a conductive adhesive bonding process, or the like, the head ends of two thermocouple wires 104 are welded, covered by a thermocouple wire head end insulating layer 105, and then the head ends of two thermocouple wires 104 and the radio frequency line 103 and the electrode 102 are welded together. 102 are arranged in an isolating manner.

As shown in FIG. 15 , a spiral-shaped wire 106 is further arranged in a lumen in the outer tube 101. The spiral-shaped wire 106 is fixed at a section in a spiral deformation area, and is used to support the spiral shape of the electrode holder. Indeed, the electrode holder can directly adopt the spiral shape, so that the spiral-shaped wire 106 can be omitted. For example, when the outer tube is manufactured using a memory alloy or polymer materials, the arrangement of the spiral-shaped wire 106 can be omitted.

As shown in FIG. 16 , a support wire 107 is disposed in a central lumen in the catheter body and the electrode holder, the support wire 107 may be movably disposed in the central lumen, or may be fixed in the central lumen, or the support wire 107 may be disposed in another lumen in the catheter body and the electrode holder. A developing head may be disposed at a head end of the support wire 107, and is used to take snapshot images inside a target lumen. In addition, a flexible guide wire 109 may be disposed at a front end of the support wire 107. The flexible guide wire 109 may be a straight-headed flexible guide wire or may be a curved-headed flexible guide wire as shown in the figure, so that the radiofrequency ablation catheter can directly enter a vessel without a guiding catheter/sheath, thereby simplifying operations in a surgery.

As can be learned from FIG. 14 to FIG. 19, a lumen used to accommodate a wall fixation adjustment wire 108 is further disposed in the catheter body. A rear section of the wall fixation adjustment wire 108 is slidably disposed in a lumen in the catheter body, and a rear end 180 of the wall fixation adjustment wire 108 extends out of the catheter body and then extends into the control handle 120, and then extends out of the control handle 120 and is connected to a control component 122 on a peripheral device (referring to FIG. 19). The wall fixation adjustment wire 108 can be moved back and forth in the lumen of the catheter body. The lumen used to accommodate the wall fixation adjustment wire 108 may be the central lumen, or it may be one of multiple eccentric lumens distributed on the periphery of the central lumen. As shown in FIG. 14, a front section of the wall fixing adjustment wire 108 protrudes out of a hole 112 which is near a rear end of the electrode holder to be on the outside of the electrode holder and is exposed outside the electrode holder; and a front end of the wall fixing adjustment wire 108 returns into the inside of the electrode holder from a hole 111 which is near a front end of the electrode holder and is fixed.

The location where the front end of the wall fixing adjustment wire 108 is fixed may be different. The front end of the wall fixing adjustment wire 108 may be fixed at the front end of the electrode holder, or it may be fixed at the front end of the support wire 107, or it may be fixed at the spiral-shaped wire 106, or it may penetrate through a corresponding lumen in the electrode holder and the catheter body and return to the rear end of the catheter body, and is fixed at the control component 122 with the rear end of the wall fixing adjustment wire 108.

Specifically, in a structure shown in FIG. 16, the front end of the wall fixing adjustment wire 108 returns into the electrode holder from the hole 111 which is near the front end of the electrode holder, and then returns to the rear end of the catheter body with the rear end of the wall fixing adjustment wire 108 through a lumen in the electrode holder and the catheter body. Then, the front end and the rear end of the wall fixing adjustment wire 108 may be fixed together on a same control component 122 shown in FIG. 19, or for the front end and the rear end of the wall fixing adjustment wire 108, one end is fixed on a control handle housing 120, and the other end is fixed on the control component 122. A diameter of a spiral section of the electrode holder can be changed by pulling the control component 122.

Of course, the front end of the wall fixing adjustment wire 108 can also be simply fixed at the front end of the electrode holder, or is fixed at the front end of the support wire 107, or is fixed at a particular part of the support wire 107 and which is located in the electrode holder, or is fixed at a particular part of the spiral-shaped wire 106, or is fixed in a lumen in the electrode holder, as long as the front end can be fixed. Therefore, when the wall fixing adjustment wire 108 is pulled from the rear end, under the effect of the wall fixing adjustment wire 108, the electrode holder is retracted and deformed, the diameter of the spiral shape of the electrode holder increases, and the axial distance between multiple spiral shapes is reduced. When the front end of the wall fixing adjustment wire 108 is fixed on the support wire 107 or the spiral-shaped wire 106, the wall fixing adjustment wire 108 and the support wire 107/the spiral-shaped wire 106 can be manufactured using a single material. In this case, it can be understood that the wall fixing adjustment wire 108 is a thin filament branching off from the support wire 107/the spiral-shaped wire 106 backward.

For example, in a structure shown in FIG. 18 , the front end of the wall fixation adjustment wire 108 is fixed with the front end of the spiral-shaped wire 106. In this case, the spiral-shaped wire 106 and the wall fixation adjustment wire 108 can be manufactured using the same thin filament, and the wall fixation adjustment wire 108 and the spiral-shaped wire 106 are respectively bifurcations of two thin filaments that branch from their front ends to the rear. A bifurcation corresponding to the spiral-shaped wire 106 is fixed in a particular lumen in the electrode holder, and a rear section of a bifurcation corresponding to the wall fixation adjustment wire 108 can be slid into a lumen in the electrode holder and/or in the catheter body. When the wall fixing adjustment cable 108 and the spiral-shaped cable 106 are manufactured using different materials (for example, the spiral-shaped cable 106 uses a tube material, and the wall fixing adjustment cable 108 uses a thin filament), the front end/front section of the wall fixing adjustment cable 108 and the spiral-shaped cable 106 may be assembled together by welding, riveting, adhering or the like.

Furthermore, as can be further learned from FIG. 19, in the above structure, a button control component 121 is further disposed on the control handle 120. The end 170 of the support wire 107 penetrates outside the catheter body and then enters the control handle 120, and is fixed on the button control component 121. In addition to being disposed on the control handle 120 shown in the figure, the control component used to connect to the end of the support wire 107 may be further disposed on the outside of the control handle 120 as the control component 122. Similarly, the control component used to connect to the wall fixing adjustment wire 108 may also be disposed on the control handle 120 as the button control component 121.

FIG. 20A to FIG. 23B are schematic diagrams of states of use of the radiofrequency ablation catheter having a spiral structure in lumens of different diameters according to the second embodiment provided in the present invention. As shown in FIG. 20A and FIG. 20B, an radiofrequency ablation catheter is used as an example for which an initial diameter ÓB of a spiral-shaped electrode holder is 10 mm, an axial distance between the first and last electrodes is A. When the radiofrequency ablation catheter extends into a sheath of Ó2 mm, the shape of the electrode holder approaches a straight line shape, as shown in FIG. 21. When the radiofrequency ablation catheter extends into a vessel of Ó4 mm from a sheath, the diameter ÓB-3 of the spiral shape of the electrode holder is limited by the vessel diameter to about 4 mm. In this case, under the effect of natural expansion of the electrode holder, the electrode is in close contact with the vessel wall, and the axial distance (A-3) between the first and last electrodes is greater than A (referring to FIG. 22). As shown in FIG. 23A and FIG.

23B, when the radiofrequency ablation catheter is extended into a vessel of Ó12 mm from a sheath, after the electrode holder is naturally expanded, because the initial diameter ÓB of the electrode holder is smaller than the diameter of a target lumen, the electrode 102 cannot realize wall fixation. In this case, the diameter of the spiral shape of the electrode holder can be increased to ÓB-4 by pulling the wall fixation adjustment wire 108 backward, which is equal to the diameter of the target lumen, and under the effect of the wall fixation adjustment wire 108, the multiple electrodes 102 are in close contact with the vessel wall. In this case, the axial distance between the first and last electrodes is reduced to A-4, and the axial distance between multiple electrodes is reduced, but because the diameter of the target lumen is relatively large, the mutual impact between the ablation effects of the multiple electrodes can be avoided, thereby avoiding excessive ablation. In addition, as can be further learned from the side views shown in FIG. 20B and FIG. 23B, under the effect of the wall fixing adjustment wire 108, the axial distance between the multiple electrodes 102 that are evenly distributed in the spiral shape of the electrode holder is reduced, and the spiral distance does not change.

In FIG. 20A to FIG. 23B, the electrode holder whose OB is 10 mm is used as an example for description. When the initial diameter of the spiral shape of the electrode holder is another value (such as 6 mm or 8 mm), similarly, when the electrode holder enters a relatively small vessel, under the effect of the natural expansion of the spiral shape electrode holder, the multiple electrodes can all be in a good state of fixing to the wall. When the electrode holder enters a target lumen whose diameter is larger than the initial diameter of the spiral shape, as shown in FIG. 23A and FIG. 23B, the multiple electrodes can also all be in close contact with the wall of a vessel by pulling the wall fixing adjustment wire, and are in a good state of fixing to the wall.

Third realization

A radiofrequency ablation catheter shown in FIG. 24 has a structure similar to that of the radiofrequency ablation catheter in the second embodiment, and for a retraction state of the radiofrequency ablation catheter, see FIG. 25. FIG. 26A and FIG. 26B are respectively schematic diagrams of usage states of a control handle 120 of the radiofrequency ablation catheter in different states.

Specifically, a spiral-shaped wire 106 is arranged in an electrode holder, and a support wire 107 is arranged in a catheter body and in the electrode holder. A part that is of the support wire 107 and that corresponds to the electrode holder is exposed outside the electrode holder. A part which is the support wire 107 and which corresponds to the catheter body is disposed in a particular lumen in the catheter body, and a rear end of the support wire 107 penetrates outside the catheter body and then is fixed in a control component 125 disposed in a control handle 120. The support wire 107 is pulled to change a spiral shape of the electrode holder, and the support wire 107 also has a function of a wall fixing adjustment wire 108. That is, a rear section of the wall fixing adjustment wire 108 is slidably disposed in a particular lumen in the catheter body, and a rear end of the wall fixing adjustment wire 108 is connected to the control handle 120. A front section of the wall fixing adjustment wire 108 penetrates outside the electrode holder from a hole 112 and then is exposed outside the electrode holder. After the front end of the wall fixing adjustment wire 108 returns into the inside of the electrode holder from a hole 111, the front end of the wall fixing adjustment wire 108 penetrates out of a front end of the electrode holder and is fixed or limited on the outside. The wall fixing adjustment wire 108 is also a catheter body support wire. A developing head and/or a flexible guide wire 109 may be provided on the front end of the wall fixing adjustment wire 108.

As shown in FIG. 26A and FIG. 26B, in this embodiment, only one control component 125 connected to the support wire 107 may be arranged on the control handle 120. In this case, the control component 125 is used to adjust a telescopic state of the electrode holder. The control component 125 is pushed backward from a location shown in FIG. 26A to a location shown in FIG. 26B, and the support wire 107 may be pulled backward, that is, the wall fixing adjustment wire 108 is pulled backward, so that the diameter of the spiral shape of the electrode holder increases.

Fourth realization

A radiofrequency ablation catheter shown in FIG. 27 has a structure similar to that of the radiofrequency ablation catheter of the second embodiment. FIG. 28 shows a structure of a support wire 107 in the radiofrequency ablation catheter of the fourth embodiment.

In this embodiment, the structure of a wall fixation adjustment wire 108 is the same as in the second embodiment. A rear section of the wall fixation adjustment wire 108 is slidably disposed in a particular lumen in a catheter body, and a rear end of the wall fixation adjustment wire 108 is connected to a control component 122 disposed in a control handle 120 or protrudes out of a control handle 120 and then is connected to a control component 122 in a peripheral device. A front section of the wall fixation adjustment wire 108 exits an electrode holder from a hole 112 and is then exposed outside the electrode holder. After the front end of the wall fixation adjustment wire 108 returns into the inside of the electrode holder from a hole 111, the front end of the wall fixation adjustment wire 108 may be fixed at a front end of the electrode holder or may be fixed at a front end of the support wire 107, or may penetrate through a corresponding lumen in the electrode holder and the catheter body and return to a rear end of the catheter body, and is fixed in a housing of the control handle 120 or the control component 122 with the rear end of the wall fixation adjustment wire 108. The diameter of a spiral section of the electrode holder may be changed by pulling the control component 122.

In this embodiment, a spiral-shaped wire is not arranged independently. As shown in FIG. 28, by pre-forming, a part which is a front part of the support wire 107 and which corresponds to the electrode holder is formed into a spiral shape to form a spiral-shaped section 176. The support wire 107 is fixed in a particular lumen in the electrode holder and in the catheter body, so that a corresponding part of the electrode holder may be formed into a spiral shape.

In the second embodiment and the fourth embodiment, the wall fixation adjustment wire 108 and the support wire 107 may both be arranged in a single lumen in the catheter body, or may be arranged independently in a single lumen in the catheter body, respectively.

Fifth realization

A radiofrequency ablation catheter shown in FIG. 29 has a structure similar to that of the radiofrequency ablation catheter of the second embodiment. FIG. 30 shows structures of a support wire 107 and a wall fixing adjustment wire 108 in the radiofrequency ablation catheter in the fifth embodiment, where the support wire 107, the wall fixing adjustment wire 108 and a spiral-shaped wire 106 are integrally arranged.

In this embodiment, the support wire 107 is arranged in a catheter body and an electrode holder, and a spiral-shaped wire is not independently arranged in the electrode holder. As shown in FIG. 30, by pre-forming, a portion which is a front portion of the support wire 107 and which corresponds to the electrode holder is spirally shaped to form a spiral-shaped section 176.

The wall fixing adjustment wire 108 and the support wire 107 are integrally arranged. A front end of the wall fixing adjustment wire 108 is fixed to the support wire 107, or the wall fixing adjustment wire 108 is a thin filament branching from the support wire 107 to the outside. A front section of the wall fixing adjustment wire 108 penetrates outside the electrode holder from a hole 111 and then is exposed outside the electrode holder, and returns to the inside of the electrode holder/catheter body from a hole 112. Then, a rear section of the wall fixing adjustment wire 108 slidably penetrates through a particular lumen in the catheter body and returns to a rear end of the catheter body, and is fixed in a control component 122. A diameter of a spiral section of the electrode holder can be changed by pulling the control component 122.

In this embodiment, the rear section of the wall fixation adjustment wire 108 and the support wire 107 may be disposed in a particular lumen in the catheter body, or they may be disposed independently in another lumen in the catheter body.

Sixth realization

FIG. 31A and FIG. 31B are schematic structural diagrams of a radiofrequency ablation catheter according to the sixth embodiment.

As shown in FIG. 20B and FIG. 23B , in the second embodiment and the fifth embodiment, although the wall fixing adjustment wire 108 is arranged in an eccentric lumen in the catheter body, a part that is of the wall fixing adjustment wire 108 and that is exposed outside the electrode holder is still located near a central location of the spiral shape of the electrode holder. When the wall fixing adjustment wire 108 is pulled back, the electrode holder is axially retracted and the wall fixing adjustment wire 108 penetrates through the central location of the spiral shape. When the spiral shape of the electrode holder is pulled to be approximately a straight line, the part that is of the wall fixing adjustment wire 108 and that is exposed outside the electrode holder is almost parallel to the outer tube 101 of the electrode holder.

Unlike the second embodiment to the fifth embodiment, in the sixth embodiment, a wall fixing adjustment wire 108 is not arranged near a central location of a spiral-shaped electrode holder, but is arranged, eccentrically, at a location on an outer circumference of the spiral shape. As shown in FIG. 31A and FIG. 31B, when the wall fixing adjustment wire 108 is arranged, eccentrically, at a location on the outer circumference of the spiral shape of the electrode holder, a part that is of the wall fixing adjustment wire 108 and that is exposed outside the electrode holder does not penetrate through the inside of the spiral shape, but is wound around an outer side of the spiral shape. When the wall fixing adjustment wire 108 is pulled back, a spiral section circle or more than one spiral section circle located between the holes 111 and 112 in the electrode holder is retracted and deformed, and a new spiral shape is obtained, so that the existing diameter of the spiral shape increases, and the diameter increases.

By this adjustment mode, the diameter of the retracted spiral shape can be greatly increased. In an ideal case, the electrode holder can be adapted to a vessel whose diameter is larger than the diameter of a single spiral section of the electrode holder. Because a diameter range of a human vessel is set, the initial diameter of the spiral shape of the electrode holder on the radiofrequency ablation catheter can be reduced, so that it is convenient for the radiofrequency ablation catheter to enter a vessel and move in the vessel.

Seventh realization

FIG. 32A to FIG. 34B are schematic structural diagrams of a radiofrequency ablation catheter according to the seventh embodiment of the present invention. There is a fixing point between a part of a wall fixing adjustment wire 108 that is exposed outside an electrode holder and the electrode holder. A front end and a rear end of the wall fixing adjustment wire 108 both penetrate from a rear end of a catheter body and are fixed on a control handle 120 or are externally arranged on corresponding control components outside a control handle 120.

As shown in FIG. 32A and FIG. 32B, when the wall fixing adjustment wire 108 is not taut, the part that is of the wall fixing adjustment wire 108 and that is exposed outside the electrode holder is loose. A particular point of the wall fixing adjustment wire 108 that is exposed outside the electrode holder is fixed on a particular spiral section of the electrode holder, and the point may be directly fixed on an outer tube or may be fixed in a hole in an outer tube. In order to maintain a smooth outer wall of the electrode holder and prevent a fixing point from scratching the target lumen, it is recommended to arrange the fixing point in the hole of the outer tube 101.

Specifically, as shown in FIG. 33 , in this embodiment, there is an attachment point 113 between the wall fixing adjustment wire 108 and a middle portion of the electrode holder. A forward section 181 of the wall fixing adjustment wire 108 is wound forwardly around the outside of the electrode holder from the attachment point 113, returns to the inside of the electrode holder from a hole 111 which is near a forward end of the electrode holder, and returns to the inside of the control handle 120 through a lumen in the electrode holder and in the catheter body. A rear section 182 of the wall attachment adjustment cable 108 wraps back around the outside of the electrode holder from the attachment point 113, returns into the interior of the electrode holder from a hole 112 that is near a rear end of the electrode holder, and returns into the interior of the control handle 120 through a lumen in the electrode holder and the catheter body. The front section 181 and the rear section 182 of the wall attachment adjustment cable 108 may return to the control handle 120 through a single lumen in the electrode holder and the catheter body, or they may respectively return to the control handle 120 through different lumens, as shown in FIG. 33. A control component may be arranged on the control handle 120 and is used to fix the front section end 181 of the wall fixing adjustment cable 108 and the rear section end 182 of the wall fixing adjustment cable 108. Alternatively, two control components may be arranged and are used to respectively fix the front section end 181 of the wall fixing adjustment cable 108 and the rear section end 182 of the wall fixing adjustment cable 108, so that the front section 181 and the rear section 182 of the wall fixing adjustment cable 108 are respectively controlled.

The front section 181 of the wall fixing adjustment cable 108 is used to control the increase in diameters of one or more circles of spiral sections that are of the electrode holder and that are located between the hole 111 and the fixing point 113. The rear section 182 of the wall fixing adjustment cable 108 is used to control the increase in diameters of one or more circles of spiral sections that are of the electrode holder and that are located between the hole 112 and the fixing point 113. As shown in FIG. 34A and FIG. 34B, when the rear section 182 of the wall fixing adjustment wire 108 is tightened, the fixing point 113 is close to the hole 112 in the electrode holder, a diameter of a spiral section circle located between the fixing point 113 and the hole 112 continuously approaches an initial diameter OB of the spiral shape of the electrode holder, so that a better wall fixing effect is obtained. More than one spiral section circle is deformed into a new spiral shape, and a diameter of the new spiral shape exceeds the initial diameter OB of the spiral shape of the electrode holder, so that the diameter increases. Similarly, when the front section 181 of the wall fixing adjustment wire 108 is tightened, the hole 111 in the electrode holder is close to the fixing point 113, a diameter of a spiral section circle located between the hole 111 and the fixing point 113 continuously approaches the initial diameter OB of the spiral shape of the electrode holder, so that a better wall fixing effect is obtained. More than one spiral section circle is deformed into a new spiral shape, and a diameter of the new spiral shape also exceeds the initial diameter OB of the spiral shape of the electrode holder, so that the diameter increases and a larger diameter for wall fixing and a better wall fixing effect are obtained.

The front section 181 and the rear section 182 of the wall fixing adjustment wire can be respectively controlled by two single control components correspondingly connected to the front section 181 and the rear section 182, to independently adjust a diameter of a different part in the electrode holder; or they can be controlled together by a single control component, to control the increase of a total diameter of multiple spiral sections of the electrode holder. In addition, when the end of the front section 181 of the wall fixing adjustment wire and the end of the rear section 182 of the wall fixing adjustment wire are respectively fixed on different control components, if the front section 181 and the rear section 182 of the wall fixing adjustment wire are pulled at the same time, different parts of the electrode holder can be deformed at the same time, to adjust the diameter of an entire electrode holder, to make the electrode holder achieve an axial retraction effect shown in FIG.

34A. Therefore, a spiral diameter after increasing the diameter can achieve the effect shown in FIG. 34B. The front section 181 and the rear section 182 of the wall fixing adjustment wire 108 can be used to respectively control the increase in diameter of one or more circles of spiral sections that are of the electrode holder and that are located between the hole 112 and the fixing point 113, and located between the hole 111 and the fixing point 113. Therefore, an increased diameter is equal to or even larger than the initial diameter shown in FIG. 32B, so that a better wall fixing effect can be obtained, and a target lumen whose diameter is changed within a larger range can be considered.

Eighth realization

In the eighth embodiment, a wall fixing adjustment wire 108 disposed on a radiofrequency ablation catheter is formed of multiple wire strands. A front end of each wire strand is fixed on an electrode holder; and a rear end is wound around a spiral section of the electrode holder from the outside and then enters the inside of the electrode holder or a catheter body, and then penetrates out of the end of the catheter body through a lumen in the catheter body and is fixed on a corresponding control component disposed on a control handle 120, or a rear end penetrates through a control handle 120 and then is fixed on a corresponding control component on a peripheral device. The multiple wire strands are respectively used to independently control diameters of different spiral sections of the electrode holder.

In a structure shown in FIG. 35 , the wall fixing adjustment cable 108 is formed by two wire strands 184 and 185. The front ends of the two wire strands 184 and 185 are fixed together at a particular point on the electrode holder, to form a fixing point 183. The rear ends of the two wire strands 184 and 185 are respectively wound around different spiral sections of the electrode holder, enter the interior of the electrode holder or the catheter body, return to the rear end through lumens in the electrode holder and the catheter body, and are fixed to corresponding control components on the control handle 120. A structure of the wall fixing adjustment cable 108 having two wire strands is basically the same as the structure in the seventh embodiment, which both can be used to respectively control the increase in diameter of spiral sections of a front section and a rear section of the electrode holder. Alternatively, the structure of the seventh embodiment can be directly understood as a case where the wall fixing adjustment cable 108 in the eighth embodiment uses two strands of cables.

When the wall fixing adjustment cable 108 has more than two wire strands, a front end of each wire strand is fixed on the electrode holder, a part that is near the front end (i.e., near the fixing point) is exposed outside the electrode holder, a rear end enters the interior of the electrode holder from holes arranged at different locations in the electrode holder, returns to the control handle 120 through a same lumen or different lumens in the electrode holder and the catheter body, and is fixed on a corresponding control component. The fixing points of the multiple wire strands on the electrode holder may be the same, may be different, or may not be exactly the same. When the fixing point of the multiple wire strands on the electrode holder is not exactly the same, every two wire strands may have a common fixing point on the electrode holder, and for the adjustments of the two wire strand structures, see the structure shown in FIG. 35. When the fixing point of the multiple wire strands on the electrode holder is the same, as shown in FIG. 36A, front ends of different wires may be fixed on the front end A of the electrode holder. Then, the rear ends of the wire strands respectively enter the inside of the electrode holder from different holes B, C and D and more holes in the electrode holder, and penetrate out of the end of the catheter body through the electrode holder and the catheter body. The end E of each of the multiple wire strands is fixed on a corresponding control component. Alternatively, as shown in FIG. 36B, the front ends of different wires may be fixed on a side D' at a rear part of the electrode holder. Then, the rear ends of the wires respectively enter the inside of the electrode holder from different holes A', B' and C' and more holes that are located at a front part of the electrode holder, and penetrate out of the end of the catheter body through the electrode holder and the catheter body. The end E' of each of the plurality of wire strands is fixed to a corresponding control component disposed on the control handle 120 or to a corresponding control component on a peripheral device. Each wire strand enters the interior of the electrode holder from a different location on the electrode holder, so that a single wire can be pulled to control a diameter change of a spiral section between a fixing point located at the front end and a location where the wire enters the electrode holder. Indeed, the above plurality of wire strands can also be fixed to a same control component on the control handle 120, to adjust the overall diameter of the electrode holder.

When multiple control components are used to respectively control different spiral sections of the electrode holder, after the radiofrequency ablation catheter enters a target location, the corresponding spiral sections of the electrode holder can be expanded section by section according to requirements, that is, only one spiral section requiring radiofrequency is expanded, so as to increase the flexibility of adjusting diameters of different spiral sections of the electrode holder, and reduce the difficulty of adjusting the wall fixation of the radiofrequency ablation catheter.

In short, a wall-fixing adjustment wire is arranged on a radiofrequency ablation catheter having a spiral structure, and the diameter of a spiral shape of an electrode holder can be changed by pulling the wall-fixing adjustment wire backward, so that the wall-fixing state of an electrode is changed, so that the radiofrequency ablation catheter can adapt to vessels of different diameters. In addition, the wall-fixing adjustment wire can also use a multi-wire structure, so as to respectively control different spiral sections of the radiofrequency ablation catheter and reduce the difficulty of diameter adjustment.

In actual clinical treatment, the radiofrequency ablation catheter and the radiofrequency ablation device provided in the present invention can be applied to ablation of nerves of vessels or tracheas in different parts and vessels or tracheas of multiple different diameters. For example, the radiofrequency ablation catheter and the radiofrequency ablation device are applied to ablation of nerves in a renal artery to treat a patient with resistant hypertension, are applied to ablation of nerves in a celiac artery to treat a patient with diabetes, in another example, are applied to ablation of the vagus nerve branch in a trachea/bronchus to treat an asthmatic patient, and are applied to ablation of the vagus nerve branch in dodecadactylon to treat a patient with duodenal ulcer. Furthermore, the radiofrequency ablation catheter and the radiofrequency ablation device can be further applied to ablation of nerves in other vessels or tracheas such as a pelvis or a pulmonary artery. It should be noted that the radiofrequency ablation catheter provided in the present invention is not limited to the above-listed applications in clinical treatment and can be further applied to ablation of nerves in other parts.

The radiofrequency ablation catheter having a spiral structure provided in the present invention has been described above, and the present invention further provides a radiofrequency ablation device including the radiofrequency ablation catheter. In addition to the radiofrequency ablation catheter, the radiofrequency ablation device further includes a radiofrequency ablation host connected to the radiofrequency ablation catheter. A supporting wall fixing adjustment wire (and a branched adjustment wire thereof) or a wall fixing adjustment wire in an electrode holder penetrates through a catheter body and then is connected to a corresponding control handle. The shape of the electrode holder can be changed by pulling the supporting wall fixing adjustment wire by the control handle, so that it is convenient to enter a target lumen and the wall fixing state in the target lumen is good. The shape of the electrode holder can be changed by pulling the wall fixing adjustment wire by the control handle, so that the wall fixing states of the electrode holder in target lumens of different diameters are good. In addition, a radio frequency line and a thermocouple wire in the electrode holder are respectively connected to corresponding circuits in the radio frequency ablation device through the catheter body, so that the radio frequency ablation device implements radio frequency control and temperature monitoring on multiple electrodes. For the adjustments of the control handle and the settings of the radio frequency ablation device, reference is made to the previous patent applications disclosed by the applicant, and the specific structures of the control handle and the radio frequency ablation device are not described in detail again herein.

The radiofrequency ablation catheter having a coil structure and the device thereof provided in the present invention have been described in detail above. For a person having ordinary skill in the art, any obvious modifications made to the present invention without departing from the scope of the appended claims will be within the protection scope of the present invention.

Claims (6)

1. A radiofrequency ablation catheter having a coiled structure, comprising an elongated catheter body, wherein a coil-shaped electrode holder is disposed at a forward end of the catheter body, one or more electrodes (102) are disposed on the electrode holder, and a control handle (120) is disposed at a rear end of the catheter body, wherein A shape and diameter of the spiral shape of the electrode holder are changed by pulling or pushing a wall fixing adjustment wire (108), wherein a rear section of the wall fixation adjustment cable (108) is slidably disposed in a lumen in the catheter body; a rear end (180) of the wall fixation adjustment cable (108) is connected to a control component (122) disposed in the control handle (120), or a rear end (180) of the wall fixation adjustment cable (108) penetrates through the control handle (120) and is then connected to a control component (122) in a peripheral device; and a front section of the wall fixation adjustment cable (108) penetrates outside the electrode holder and is then exposed outside the electrode holder, characterized in that a front end of the wall fixation adjustment cable (108) returns into the electrode holder, then returns to the rear end of the catheter body through a lumen in the electrode holder and the catheter body, and is fixed in the control handle (120) or is fixed in the control component (122). 2. The radiofrequency ablation catheter having a coiled structure according to claim 1, further comprising: a support wire (107) slidably disposed in a particular lumen in the catheter body and the electrode holder. 3. A radiofrequency ablation catheter having a coiled structure according to claim 2, wherein a developing head and/or a flexible guide wire (109) are disposed at a front end of the support wire (107). 4. A radiofrequency ablation catheter having a coiled structure according to claim 2, wherein a second control component (121) fixed with the rear end (170) of the support wire (107) is arranged on the control handle (120) or on the outside of the control handle (120). 5. The radiofrequency ablation catheter having a spiral structure according to claim 1, further comprising: a support wire (107) fixed in a particular lumen in the catheter body and the electrode holder, wherein a part of the support wire (107) in the electrode holder is formed into the spiral shape, to form a spiral-shaped section (176). 6. A radiofrequency ablation device, comprising the radiofrequency ablation catheter according to any one of claims 1 to 5 and a radiofrequency ablation device that is connected to the radiofrequency ablation catheter.